Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics

NCT02316678 | Completed Results

• 1 other identifier: 818347
• Study Type: observational
• Target: 9,573
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will test the hypothesis that that greater efficacy of anti-tumor necrosis factor (antiTNF) therapy results in reduced need for bowel resection surgery, fewer serious infections, and reduced short term mortality risks, and therefore has a more favorable benefit to harm profile than corticosteroids for inflammatory bowel disease.

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn's Disease

Keywords

Patient Preference

Outcome Measures

Primary Outcomes (1)

• Mortality Rate

  Incidence of death per 1000 person-years Outcome Measure Time Frame:Follow-up was from the date that the participant first met the criteria for either prolonged corticosteroid use or new anti-TNF use until either the patient died, discontinued enrollment in Medicaid or Medicare Part A, B, or D, reached age 90, was newly diagnosed with other immune-mediated diseases or AIDS, or reached the end of the available data, whichever came first, assessed up to 13 years. Follow-up of patients with UC also ended if they were diagnosed with a fistula, as this would usually change the diagnosis to CD.

  See Outcome Measure Description above

Study Arms (2)

anti-TNF - no intervention

Patients who are new users of anti-TNF therapy

Other: No intervention

Corticosteroids - no intervention

Patients initiating corticosteroids

Other: No intervention

Interventions

No intervention OTHER

There is no intervention

Corticosteroids - no intervention; anti-TNF - no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will use Medicare data from 2006-2011. Patients will be required to have at least two diagnosis of inflammatory bowel disease within the 6 months prior to initiating anti-TNF therapy or coritcosteroids as defined below. To assure full coverage, patients will be required to have Parts A, B, and D Medicare coverage.

You may qualify if:

• \. Patients will be required to have at least two diagnosis of inflammatory bowel disease within the 6 months prior to initiating anti-TNF therapy or corticosteroids. To assure full coverage, patients will be required to have Parts A, B, and D Medicare coverage.

You may not qualify if:

• Diagnosis of rheumatoid arthritis, psoriasis, ankylosing spondylitis, or psoriatic arthritis in the 6 months period prior to initiation of the therapy.
• Less than 6 months of follow-up time within the data source prior to initiation of the therapy.
• Diagnosis of cancer in the 6 months prior to initiation of the study medication.
• Initiation of anti-TNF therapies within the first 6 months following surgery.
• Patients who are in managed care plans (Medicare Part C).

Sponsors & Collaborators

• University of Pennsylvania: lead
• Crohn's and Colitis Foundation: collaborator
• University of Alabama at Birmingham: collaborator
• Duke University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Bewtra M, Reed SD, Johnson FR, Scott FI, Gilroy E, Sandler RS, Chen W, Lewis JD. Variation Among Patients With Crohn's Disease in Benefit vs Risk Preferences and Remission Time Equivalents. Clin Gastroenterol Hepatol. 2020 Feb;18(2):406-414.e7. doi: 10.1016/j.cgh.2019.05.010. Epub 2019 May 14.

  PMID: 31100456 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease; Patient Preference

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: James Lewis
• Organization: University of Pennsylvania

lewisjd@upenn.edu

215-573-5137

Study Officials

• James D Lewis, MD, MSCE

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 15, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 19, 2017
• Results First Posted: March 10, 2017

Record last verified: 2017-04

Locations

US (1)